# K012103: Bandview System

- Pathway: 510(k) (Traditional)
- Applicant: Applied Spectral Imaging, Ltd.
- Decided: Sep 14, 2001 after 71 days
- Product code: LNJ (Analyzer, Chromosome, Automated)
- Device class: 2
- Regulation: 21 CFR 864.5260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K902311 (1990). 2 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940240: Ikaros, Metasystems GmbH (1995) Summary page 2.
- K902311: Genevision - Computer Assisted Chromosome Karyo., Applied Imaging Corp. (1990) Summary page 2.

## Most influential descendants
- K030192: Duet System (2003), 13 descendants of its own
- K040591: Duet System (2004), 12 descendants of its own
- K050840: Modification to Duet System (2005), 7 descendants of its own
- K061602: Duet System (2007), 5 descendants of its own
- K050236: Fishview (2005), 4 descendants of its own

## Indications for use
The BandView system is intended to be used for karyotyping with real-time microscope images from cultured and stained cell specimens in their metaphase. The system works with brght field and fluorescent samples with all currently applied banding techniques including G-banding and DAPI-banding. All specimens suitable for banding analysis including from amniotic fluid, peripheral blood, chorionic willus, bone marrow, and tissue can be used without limitation to specific diseases. Karyotyping is normally applied for the pre and postnatal diagnosis of birth defects, chromosome abnormalities, genetic diseases (such as Down's syndrome), cancer, and for the follow up of cancer treatment. The BandView system does not locate metaphase spreads; it does not rank the given cells according to quality; it does not automatically classify chromosomes; it does require and relies completely on the operator to manipulate the digitized MICToSCope 1mages.

Source page: https://510kreport.com/device/K012103
Methodology: https://510kreport.com/methodology